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The purpose is to assess the safety profile and performance of a femoral resurfacing implant for localized chondral lesions.
The implant's safety profile will be assessed by incidence of any subject having any of the seven identified implant-related clinical undesirable side effects. This will be analyzed with a one-side exact binomial test on significance level 0.05, at 24 months post-operatively.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Surgery | Experimental | Implant surgery |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Implant surgery | Device | surgery |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with Adverse Events | The primary efficacy analysis in this study is to ascertain that the incidence of at least one subject having any of the seven identified clinical undesirable side effects is lower than 38 % (risk profile of the comparator) up to the 24 months analysis in the PP population. This will be analyzed with a one-side exact binomial test on significance level 0.05 | 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical performance | Clinical performance, by questionnaires and knee ROM measurements. | 24 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Frederick Zetterberg | Episurf Medical | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Lund University Hospital, Department of Ortopedics | Lund | Sweden | ||||
| Aleris Specialistvård |
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| Stockholm |
| Sweden |
| Sports Medicine Umeå | Umeå | Sweden |